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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE DEFIB/PACING ELECTRODE

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BIO-DETEK INCORPORATED PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE DEFIB/PACING ELECTRODE Back to Search Results
Model Number 8900-4006
Device Problems Sparking (2595); Deformation Due to Compressive Stress (2889)
Patient Problem Burn(s) (1757)
Event Type  Injury  
Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that while attempting to cardiovert a patient (age & gender unknown), the electrode pads sparked and arched. Complainant alleged after removing the electrode pads, burns were found on the patient. Complainant alleged that the patient subsequently sustained a burn. The customer was unable to provide information on the degree of the burn. Please reference medwatch report 1220908-2018-02861 for the same event reported from the same customer.
 
Manufacturer Narrative
The electrode pads used were not returned for evaluation as part of this investigation. However, the images provided by the customer indicated that the patient was not prepped properly before applying the electrode pads. Review of the device activity logs showed multiple advisory messages that indicate the device was not recognizing a valid patient impedance. This report has been attributed to poor patient preparation. Please reference medwatch report 1220908-2018-02861 for the report against the device for this event. Analysis of reports of this type has not identified an increase in trend.
 
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Brand NamePRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE
Type of DeviceDEFIB/PACING ELECTRODE
Manufacturer (Section D)
BIO-DETEK INCORPORATED
525 narragansett park drive
pawtucket RI 02861
Manufacturer Contact
525 narragansett park drive
pawtucket, RI 02861
4017291400
MDR Report Key8011521
MDR Text Key125272370
Report Number1218058-2018-00083
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date06/24/2019
Device Model Number8900-4006
Device Catalogue Number8900-4006
Device Lot Number2618
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/24/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

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